Raloxifene Teva
raloxifene
Table of contents
Overview
This is a summary of the European Public Assessment Report (EPAR) for Raloxifene Teva. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Raloxifene Teva.
Authorisation details
| Product details | |
|---|---|
| Name |
Raloxifene Teva
|
| Agency product number |
EMEA/H/C/001075
|
| Active substance |
raloxifene hydrochloride
|
| International non-proprietary name (INN) or common name |
raloxifene
|
| Therapeutic area (MeSH) |
Osteoporosis, Postmenopausal
|
| Anatomical therapeutic chemical (ATC) code |
G03XC01
|
Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Teva B.V.
|
| Revision |
10
|
| Date of issue of marketing authorisation valid throughout the European Union |
29/04/2010
|
| Contact address |
Swensweg 5 |
Product information
08/09/2021 Raloxifene Teva - EMEA/H/C/001075 - N/0029
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Sex hormones and modulators of the genital system
Therapeutic indication
Raloxifene is indicated for the treatment and prevention of osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.
When determining the choice of raloxifene or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.